Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia

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Brief Title

Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia

Official Title

A Randomized Phase II Study of Nuclear Factor-kappa B (NF-κB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia

Brief Summary

      This randomized phase II trial studies how well choline magnesium trisalicylate with
      idarubicin and cytarabine works in treating patients with acute myeloid leukemia. Drugs used
      in chemotherapy, such as choline magnesium trisalicylate, idarubicin, and cytarabine, work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. It is not yet know whether choline magnesium trisalicylate and
      combination chemotherapy is more effective than combination chemotherapy alone in treating
      patients with acute myeloid leukemia.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine temporal changes in leukemic cell nuclear factor of kappa light chain
      enhancer of B-cells 1 (NF-kB) activity when salicylate (choline magnesium trisalicylate) is
      administered to patients with acute myeloid leukemia (AML) during induction chemotherapy.

      II. To determine toxicities associated with administration of salicylate in the setting of
      induction chemotherapy.

      III. To determine if salicylate alters the expression of NF-kB-regulated genes in AML cells.

      IV. To determine if NF-kB modulation by salicylate alters AML chemotherapy drug efflux.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive choline magnesium trisalicylate orally (PO) every 8 hours on days
      0-7, idarubicin intravenously (IV) on days 1-3, and cytarabine IV continuously on days 1-7.

      ARM II: Patients receive idarubicin IV on days 1-3 and cytarabine IV continuously on days
      1-7.

      In both arms, treatment continues in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed up periodically.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients


Condition

Adult Acute Megakaryoblastic Leukemia (M7)

Intervention

choline magnesium trisalicylate

Study Arms / Comparison Groups

 Arm I (choline magnesium trisalicylate and chemotherapy)
Description:  Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

27

Start Date

January 2009

Completion Date

April 26, 2016

Primary Completion Date

April 26, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have a diagnosis of non-M3 AML (patients with M3 subtype are excluded);
             determination of the presence of cytogenetic abnormalities will be by standard
             cytogenetics +/- fluorescent-in-situ (FISH) studies; additional molecular analyses for
             nucleophosmin (NPM) mutation and fms-related tyrosine kinase 3 (flt3) internal tandem
             duplication will be obtained as a part of standard care by institutional procedures

          -  Leukemic blast count > 1500/mm^3 of peripheral blood

          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =<
             3

          -  Total bilirubin < 2 times the institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 3
             times the institutional ULN

          -  Serum creatinine < 1.5 times the institutional ULN

          -  Multi gated acquisition scan (MUGA) or echocardiogram with left ventricular ejection
             fraction (LVEF) > 50%

          -  Women of childbearing potential must have a negative pregnancy test

          -  No uncontrolled psychiatric illness that the principal investigator feels will
             compromise obtaining informed consent from a patient

          -  Patient must be informed of the investigational nature of this study and must give
             written informed consent in accordance with institutional and federal guidelines;
             patients who do not provide informed consent will not be eligible for the study

        Exclusion Criteria:

          -  Any coexisting medical condition or medications precluding full compliance with any of
             the arms of the study

          -  Allergies to any investigational drugs and/or to the chemotherapeutic agents

          -  Allergies to any non-steroidal anti-inflammatory drugs (NSAIDs)/salicylates (e.g.,
             aspirin)

          -  Endoscopically documented upper or lower gastrointestinal (GI) related hemorrhage
             within last 6 months; also, patients with a clinical diagnosis of GI bleeding
             requiring blood transfusions will be excluded
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Roger Strair, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02144675

Organization ID

020803

Secondary IDs

NCI-2012-00516

Responsible Party

Principal Investigator

Study Sponsor

Rutgers, The State University of New Jersey

Collaborators

 Rutgers Cancer Institute of New Jersey

Study Sponsor

Roger Strair, Principal Investigator, Rutgers Cancer Institute of New Jersey


Verification Date

June 2018